Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Summary

The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.

Timeline

Start

2026-07-29

Primary completion

2026-12

Completion

2027-09

Publications

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• Background Wakabayashi T, Iuchi T, Tsuyuguchi N, Nishikawa R, Arakawa Y, Sasayama T, Miyake K, Nariai T, Narita Y, Hashimoto N, Okuda O, Matsuda H, Kubota K, Ito K, Nakazato Y, Kubomura K. Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial. Asia Ocean J Nucl Med Biol. 2017 Winter;5(1):10-21. doi: 10.22038/aojnmb.2016.7869.
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• Background Liu CJ, Lu MY, Liu YL, Ko CL, Ko KY, Tzen KY, Chang HH, Yang YL, Jou ST, Hsu WM, Yen RF. Risk Stratification of Pediatric Patients With Neuroblastoma Using Volumetric Parameters of 18F-FDG and 18F-DOPA PET/CT. Clin Nucl Med. 2017 Mar;42(3):e142-e148. doi: 10.1097/RLU.0000000000001529.
• Background Marner L, Nysom K, Sehested A, Borgwardt L, Mathiasen R, Henriksen OM, Lundemann M, Munck Af Rosenschold P, Thomsen C, Bogeskov L, Skjoth-Rasmussen J, Juhler M, Kruse A, Broholm H, Scheie D, Lauritsen T, Forman JL, Wehner PS, Hojgaard L, Law I. Early Postoperative 18F-FET PET/MRI for Pediatric Brain and Spinal Cord Tumors. J Nucl Med. 2019 Aug;60(8):1053-1058. doi: 10.2967/jnumed.118.220293. Epub 2019 Jan 25.
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• Background Albert NL, Weller M, Suchorska B, Galldiks N, Soffietti R, Kim MM, la Fougere C, Pope W, Law I, Arbizu J, Chamberlain MC, Vogelbaum M, Ellingson BM, Tonn JC. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas. Neuro Oncol. 2016 Sep;18(9):1199-208. doi: 10.1093/neuonc/now058. Epub 2016 Apr 21.
• Background Werner JM, Lohmann P, Fink GR, Langen KJ, Galldiks N. Current Landscape and Emerging Fields of PET Imaging in Patients with Brain Tumors. Molecules. 2020 Mar 24;25(6):1471. doi: 10.3390/molecules25061471.
• Background Bhutia YD, Babu E, Ramachandran S, Ganapathy V. Amino Acid transporters in cancer and their relevance to "glutamine addiction": novel targets for the design of a new class of anticancer drugs. Cancer Res. 2015 May 1;75(9):1782-8. doi: 10.1158/0008-5472.CAN-14-3745. Epub 2015 Apr 8.
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• Background Morana G, Piccardo A, Tortora D, Puntoni M, Severino M, Nozza P, Ravegnani M, Consales A, Mascelli S, Raso A, Cabria M, Verrico A, Milanaccio C, Rossi A. Grading and outcome prediction of pediatric diffuse astrocytic tumors with diffusion and arterial spin labeling perfusion MRI in comparison with 18F-DOPA PET. Eur J Nucl Med Mol Imaging. 2017 Nov;44(12):2084-2093. doi: 10.1007/s00259-017-3777-2. Epub 2017 Jul 27.
• Background Dunkl V, Cleff C, Stoffels G, Judov N, Sarikaya-Seiwert S, Law I, Bogeskov L, Nysom K, Andersen SB, Steiger HJ, Fink GR, Reifenberger G, Shah NJ, Coenen HH, Langen KJ, Galldiks N. The usefulness of dynamic O-(2-18F-fluoroethyl)-L-tyrosine PET in the clinical evaluation of brain tumors in children and adolescents. J Nucl Med. 2015 Jan;56(1):88-92. doi: 10.2967/jnumed.114.148734. Epub 2014 Dec 18.
• Background Galldiks N, Niyazi M, Grosu AL, Kocher M, Langen KJ, Law I, Minniti G, Kim MM, Tsien C, Dhermain F, Soffietti R, Mehta MP, Weller M, Tonn JC. Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients - a report of the PET/RANO group. Neuro Oncol. 2021 Jun 1;23(6):881-893. doi: 10.1093/neuonc/noab013.
• Background Henderson F Jr, Brem S, O'Rourke DM, Nasrallah M, Buch VP, Young AJ, Doot RK, Pantel A, Desai A, Bagley SJ, Nabavizadeh SA. 18F-Fluciclovine PET to distinguish treatment-related effects from disease progression in recurrent glioblastoma: PET fusion with MRI guides neurosurgical sampling. Neurooncol Pract. 2020 Mar;7(2):152-157. doi: 10.1093/nop/npz068. Epub 2019 Dec 8.
• Background Galldiks N, Langen KJ, Holy R, Pinkawa M, Stoffels G, Nolte KW, Kaiser HJ, Filss CP, Fink GR, Coenen HH, Eble MJ, Piroth MD. Assessment of treatment response in patients with glioblastoma using O-(2-18F-fluoroethyl)-L-tyrosine PET in comparison to MRI. J Nucl Med. 2012 Jul;53(7):1048-57. doi: 10.2967/jnumed.111.098590. Epub 2012 May 29.
• Background Banerjee A, Jakacki RI, Onar-Thomas A, Wu S, Nicolaides T, Young Poussaint T, Fangusaro J, Phillips J, Perry A, Turner D, Prados M, Packer RJ, Qaddoumi I, Gururangan S, Pollack IF, Goldman S, Doyle LA, Stewart CF, Boyett JM, Kun LE, Fouladi M. A phase I trial of the MEK inhibitor selumetinib (AZD6244) in pediatric patients with recurrent or refractory low-grade glioma: a Pediatric Brain Tumor Consortium (PBTC) study. Neuro Oncol. 2017 Aug 1;19(8):1135-1144. doi: 10.1093/neuonc/now282.
• Background Hutterer M, Nowosielski M, Putzer D, Jansen NL, Seiz M, Schocke M, McCoy M, Gobel G, la Fougere C, Virgolini IJ, Trinka E, Jacobs AH, Stockhammer G. [18F]-fluoro-ethyl-L-tyrosine PET: a valuable diagnostic tool in neuro-oncology, but not all that glitters is glioma. Neuro Oncol. 2013 Mar;15(3):341-51. doi: 10.1093/neuonc/nos300. Epub 2013 Jan 17.
• Background Gelfand MJ. Dosimetry of FDG PET/CT and other molecular imaging applications in pediatric patients. Pediatr Radiol. 2009 Feb;39 Suppl 1:S46-56. doi: 10.1007/s00247-008-1023-6. Epub 2008 Dec 16.
• Background Quinn BM, Gao Y, Mahmood U, Pandit-Taskar N, Behr G, Zanzonico P, Dauer LT. Patient-adapted organ absorbed dose and effective dose estimates in pediatric 18F-FDG positron emission tomography/computed tomography studies. BMC Med Imaging. 2020 Jan 29;20(1):9. doi: 10.1186/s12880-020-0415-4.

Drugs

Indications